Validation & Instructional Guides
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Validation Guide Category Description
Data applicable data to single-use bioreactors that demonstrate their suitability for cell culture applications
Validation data sets for depth filters to support their suitability for biotechnology and pharmaceuticals applications
Design, applications, and qualification testing that ensures membrane chromatography devices are suitable for downstream bioprocessing
Guidance to achieve and maintain a validated state ensuring process and regulatory requirements are met.
Applicable methodologies and data supporting shelf life studies and suitability for use in biopharmaceutical
Comprehensive validation data and information regarding tests conducted to validate the performance of filter cartridges and capsules
Validation data for single-use biocontainers to demonstrate their suitability for biotech and biopharmaceuticals
Validation support information containing test data on safety, compatibility, performance, and usage conditions for tangential flow filtration
Comprehensive validation data to support the qualification and validation of virus retentive filters
Instructional Guide Category Description
The manual contains all essential information for the user to make full use of the information system. This manual includes a description of the system functions and capabilities, contingencies and alternate modes of operation.